BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC3 GO¿ INTERMITTENT URINARY CATHETER

    MDR report key: 8042777 · Received November 6, 2018

    Report

    Report Number
    1018233-2018-05207
    Event Type
    Injury
    Date Received
    November 6, 2018
    Report Date
    February 25, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZD
    UDI-DI
    00801741097898
    PMA / PMN Number
    K150345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION NOTED 5 UNOPENED SAMPLES IN ORIGINAL PACKAGING. NO DAMAGES WERE NOTED ON THE EXTERIOR OF PACKAGING. THE DIP LINE AND HYDROPHILIC COATING WERE BOTH PRESENT. THE SAMPLES WERE TESTED AND THE COEFFICIENT OF FRICTION WAS PERFORMED AND EACH SAMPLE WAS CUT IN HALF IN ORDER TO TEST AS A PAIR. KINETIC COF WAS FOUND (.034, .064) TO BE WITHIN SPECIFICATION ( <0.400) FOR ALL CATHETERS TESTED.THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "REVIEW THE SELF-CATHETERIZATION PROCEDURE WITH A HEALTHCARE PROFESSIONAL. 1. ALWAYS WASH HANDS PRIOR TO USE. 2. OPEN THE CATHETER PACKAGE BY PEELING THE TAB UPWARDS WITH THE AID OF THE FINGER HOLE. 3. IF DESIRED, HANG THE PACKAGE WITH THE ADHESIVE SURFACE ON THE INNER SIDE OF THE TAB TO A NEARBY DRY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. 4. POSITIONED COMFORTABLY WITH THIGHS SPREAD APART, CLEAN THE OPENING TO THE URETHRA ¿ AND THE SURROUNDING AREA. WIPE FROM FRONT TO BACK TO AVOID FECAL CONTAMINATION. WASH YOUR HANDS AGAIN. 5. REMOVE THE CATHETER WITH THE AID OF THE INSERTION HANDLE AND ADVANCE THE CATHETER TIP INTO THE URETHRA. SLOWLY AND GENTLY INSERT THE CATHETER INTO THE URETHRA UNTIL URINE BEGINS TO FLOW (APPROXIMATELY 1-1.5" OR 2.5-3.8 CM). 6. WHEN URINE STOPS FLOWING, BEGIN TO WITHDRAW THE CATHETER. IT IS RECOMMENDED TO SLOWLY ROTATE THE CATHETER DURING WITHDRAWAL, STOPPING EACH TIME URINE BEGINS TO FLOW. CHECK THE COLOR, ODOR AND CLARITY OF THE URINE. ANY CHANGES MAY NEED TO BE REPORTED TO A HEALTH CARE PROFESSIONAL. DISPOSAL 7. PLACE THE CATHETER BACK INTO THE PACKAGE AND DISPOSE IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. DO NOT FLUSH DOWN THE TOILET. 8. WASH HANDS." CORRECTION: CONCOMITANT MEDICAL PRODUCTS AND DEVICE EVALUATED BY MFR. PATIENT CODE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING THE MAGIC 3 CATHETER; THE PATIENT EXPERIENCE SOME DISCOMFORT AND AN ALLEGED UTI (URINARY TRACT INFECTION) AND WAS PRESCRIBED ANTIBIOTICS. THE PATIENT ALSO STATED THAT SHE FEELS THAT THE PRODUCT IS NOT A GOOD FIT FOR HER ANATOMY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WAS FOUND ADEQUATE AND STATES THE FOLLOWING: "REVIEW THE SELF-CATHETERIZATION PROCEDURE WITH A HEALTHCARE PROFESSIONAL. 1. ALWAYS WASH HANDS PRIOR TO USE. 2. OPEN THE CATHETER PACKAGE BY PEELING THE TAB UPWARDS WITH THE AID OF THE FINGER HOLE. 3. IF DESIRED, HANG THE PACKAGE WITH THE ADHESIVE SURFACE ON THE INNER SIDE OF THE TAB TO A NEARBY DRY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. 4. POSITIONED COMFORTABLY WITH THIGHS SPREAD APART, CLEAN THE OPENING TO THE URETHRA ¿ AND THE SURROUNDING AREA. WIPE FROM FRONT TO BACK TO AVOID FECAL CONTAMINATION. WASH YOUR HANDS AGAIN. 5. REMOVE THE CATHETER WITH THE AID OF THE INSERTION HANDLE AND ADVANCE THE CATHETER TIP INTO THE URETHRA. SLOWLY AND GENTLY INSERT THE CATHETER INTO THE URETHRA UNTIL URINE BEGINS TO FLOW (APPROXIMATELY 1-1.5" OR 2.5-3.8 CM). 6. WHEN URINE STOPS FLOWING, BEGIN TO WITHDRAW THE CATHETER. IT IS RECOMMENDED TO SLOWLY ROTATE THE CATHETER DURING WITHDRAWAL, STOPPING EACH TIME URINE BEGINS TO FLOW. CHECK THE COLOR, ODOR AND CLARITY OF THE URINE. ANY CHANGES MAY NEED TO BE REPORTED TO A HEALTH CARE PROFESSIONAL. DISPOSAL 7. PLACE THE CATHETER BACK INTO THE PACKAGE AND DISPOSE IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. DO NOT FLUSH DOWN THE TOILET. 8. WASH HANDS." THE DEVICE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING THE MAGIC 3 CATHETER; THE PATIENT EXPERIENCE SOME DISCOMFORT AND AN ALLEGED UTI (URINARY TRACT INFECTION) AND WAS PRESCRIBED ANTIBIOTICS. THE PATIENT ALSO STATED THAT SHE FEELS THAT THE PRODUCT IS NOT A GOOD FIT FOR HER ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882582 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER MAGIC 3 CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 51814 JUCS0163 00801741097898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention